The present disclosure generally relates to a connector device and, in particular, to a connector device for establishing fluid communication between two septum sealed containers, a septum sealed container, a kit with such a connector device, and a method for transferring liquid between two septum sealed containers.
In the medical field, there is a need to transfer liquid medicaments or other medical related liquids from one container to another. For example, medical personnel routinely draw liquid medicaments from vials into syringes in order to inject the medicament to a patient.
In cases where users without professional training have to carry out such tasks, there is even a more pronounced need for such a liquid medicament transfer process to be easy, quick, inexpensive, and most importantly safe. This is for example the case in the field of diabetes therapy by continuous subcutaneous insulin infusion, where a person with diabetes carries an insulin infusion pump device continuously night and day.
In a common type of such ambulatory infusion pump devices, a disposable reservoir container is provided that holds the liquid medicament required for some days. These disposable reservoir containers typically comprise a cylinder and a piston that is slidably arranged in the cylinder. Such containers are available prefilled by the manufacturer. Alternatively, they are provided empty and filled by the user with content from another supply container such as a vial or an injection pen cartridge.
One well-known technique to transfer liquid medicament is by the use of a syringe, where the liquid is first transferred from the septum sealed supply container to the syringe, and subsequently transferred from the syringe to the disposable reservoir container. A common type of disposable reservoir container for infusion pump devices comprises a male luer connector for connecting the cylinder to the infusion line, which can also be connected to a needle for filing purposes. Thus with a removable piston shaft and a disposable needle attached to the luer connector, such containers can be directly manually filled like a syringe without the need for an additional syringe.
The filling procedure is generally carried out by an untrained person, such as the patient or a relative. The proper use of syringes and needles requires certain manual skills. Many patients with motor difficulties, such as diabetics with neuropathy or the elderly, have problems with the safe handling of syringes. In addition, accidental needle injuries, safe disposal of used needles, air free filling, and transferring the proper amount of medication without unnecessary waste are always a concern. Another problem is cross-contamination of medications between containers.
To avoid the use of a syringe with a needle for filling the disposable reservoir container, a connector device with a protected transfer needle can be used. A first member of the connector device is intended to be releasably attached to a septum sealed supply container, e.g. a vial or an injection pen cartridge, containing the liquid medicament. A second member is slideably arranged in the first member and comprises a female luer connector that can be connected to a corresponding male luer connector of a disposable reservoir container. Furthermore, it comprises a hollow transfer needle for penetrating the septum of the supply container. Prior to use, the members are in a first position, with the transfer needle of the second member being protected by the first member. After attaching the first member to the supply container, and the second member to the disposable reservoir container, the second member is pushed toward the supply container. The transfer needle penetrates the septum of the supply container, and a fluid connection between disposable reservoir container and supply container is established.
For several reasons, such as for example reusability and maintenance of sterility, the use of disposable reservoir containers that are provided sealingly closed by a septum is preferable over containers with luer connectors.
A variant of the above-mentioned connector device that allows the transfer of liquid between two septum sealed containers is known, intended to allow dissolving a solid medicament provided in a vial with liquid from an infusion bag and transferring the liquid with the reconstituted medicament back into the infusion bag.
A first cylindrically shaped member is slidably mounted in a second cylindrically shaped member and comprises a receptacle for releasably connecting to the neck of a septum sealed infusion bag. A transfer needle with two pointed ends is mounted on the first member. One half of the needle is located in the receptacle of the first member while the second half of the transfer needle is located inside of the second member. The second member comprises locking means for permanently attaching a septum sealed vial, and a seal that encloses the second end of the needle and also sealingly encloses the septum of the vial when connected to the second member.
When the first container is releasably inserted into the first member, the first end of the needle penetrates the septum of the container. A fluid connection between infusion bag and transfer needle is established. After the second container has been permanently attached to the second member, the two members are rotated around their axis, thereby going from a deactivated state, where the members cannot be shifted, to an activated state of the connector device, where the members can be shifted in regard to each other. The first member can now be pushed into the second member, and the second end of the needle penetrates first the seal of the second member and then the septum of the second container. A fluid connection between the two containers is established, and liquid can be transferred from the first container to the second container, and back.
Therefore, there is a need for a connector device for fluidly connecting two septum sealed containers that are releasably connectable to at least one septum-sealed container without having its seal penetrated, where the connector device is easily removable, allows simple and safe handling also for untrained users, is reliable and producible at low cost, and has a long shelf-time.